Bullet-Point Summary
- FDA granted conditional approval for Liavium®-CA1 (pregabalin chewable tablets) for dogs with Chiari-like malformation and syringomyelia (CM/SM)
- Product is the first veterinary pregabalin therapy approved for this indication
- CM/SM commonly affects small and toy breeds, especially Cavalier King Charles Spaniels
- Approval was supported by pilot study data demonstrating pain management and ease of administration
- Liavium®-CA1 will be available in beef-flavored chewable tablets in three strengths for dogs weighing approximately 6.6–50 pounds
- Pegasus continues pivotal clinical trials while marketing the conditionally approved product
Pegasus Laboratories, under its PRN® Pharmacal brand, announced the U.S. Food and Drug Administration has granted conditional approval for Liavium®-CA1 (pregabalin chewable tablets), a new treatment option for dogs diagnosed with Chiari-like malformation and syringomyelia (CM/SM).
The therapy becomes the first FDA conditionally approved pregabalin product for veterinary use in managing pain and clinical signs associated with CM/SM, a neurologic disorder linked to chronic neuropathic pain in dogs.
According to Pegasus, CM/SM is frequently underdiagnosed because symptoms—including phantom scratching, vocalization, and neck sensitivity—may be mistaken for behavioral changes, anxiety, or age-related issues. While the condition can occur in any breed, it is most commonly identified in small and toy breeds, particularly Cavalier King Charles Spaniels.
Pilot Data Supported Conditional Approval
Pegasus said FDA conditional approval followed results from a pilot study evaluating the product’s ability to manage pain and associated clinical signs while remaining practical for use in veterinary settings.
The company acquired TriviumVet® in 2025 and continues to evaluate Liavium®-CA1 in a pivotal U.S. clinical trial designed to support full FDA approval. Conditional approval allows the product to be marketed while additional effectiveness data are collected for the full approval process.
“Liavium-CA1 signals a turning point in canine pain management by providing veterinarians a first-of-its-kind option to effectively manage neuropathic pain,” said Dr. Heather Davis, senior director of medical affairs and veterinary services at Pegasus.
Product Availability and Safety Information
Liavium®-CA1 is expected to launch in 30 mg, 90 mg, and 180 mg beef-flavored chewable tablets. The 90 mg tablet is scored for splitting. Pegasus said the dosing configurations are intended for dogs weighing approximately 6.6 to 50 pounds.
As pregabalin is classified as a Schedule V controlled substance, veterinarians and pharmacies must comply with federal and state prescribing, dispensing, and record-keeping requirements.
Pegasus noted that adverse reactions associated with pregabalin administration in dogs may include somnolence, increased appetite, decreased activity, increased water intake, hypothermia, ataxia, and sedation. The product has not been evaluated in dogs with renal disease or in dogs that are pregnant, nursing, or intended for breeding.
About Pegasus Laboratories
Founded in 1986, Pegasus Laboratories develops and manufactures specialty animal health products focused on chronic conditions affecting dogs, cats, and horses. The company operates under PBI-Gordon Companies and also provides CDMO services and a portfolio of pharmaceuticals, supplements, and wound care products.
Information sourced from the company’s press release.
